CMO为中国制工业国际化带来契机——CMO市场和流程解析以及国际化模式探讨.docVIP

摘 要 中国制药业面临国际化的迫切需要。本文研究一条中国制药业国际化的快捷途 径——合同加工（CMO）。本文分析了国际药品 CMO 的发展背景、市场和发展 趋势，并分析了中国制药业国际化现状，阐述近年来不断增长的国际 CMO 市场 给中国制药业国际化带来的良好机遇和各种有利之处，合同加工可以帮助解决中 国制药企业国际化途中遇到的许多问题，弥补企业的不足，是一条国际化的捷径， 中国制药企业需要抓住这个良好的机会。本文还重点分析了国际合同加工的一般 流程及流程中各环节所涵盖的具体内容、技术要点、注意事项及相关欧美药事法 规等，阐述制药企业成为 CMO 需要具备的基本条件，企业在合同加工过程中需 要学习积累的国际化制药管理经验。最后介绍两种由 CMO 带动的中国制药业国 际化的发展模式，供企业参考借鉴。 关键词： 合同加工，委托生产，生产外包，制药，原料药，制剂，国际化，流程 CMO Brings the Chance of globalization to Chinese Pharmaceutical Industry ------- CMO Market and Flowchart Analysis and Globalization Model Study Abstract Chinese pharmaceutical industry is facing an urgent need of internationalization. CMO is a fast and effective way for globalization. This article studies CMO including its development background, market, trends and the flowchart. This article analyzes the international CMO market and the status quo of Chinese pharmaceutical industry to expatiate that the growing international CMO market is bringing the good chance to Chinese pharmaceutical industry. Being a CMO can help to solve most of the problems Chinese pharmaceutical industry met during their labour for globalization and make up the weakness of the enterprises. CMO is a short cut for Chinese pharmaceutical industry globalization. Chinese pharmaceutical enterprises should grasp this golden opportunity. This article lays special stress on analyzing the general flowchart of international contract manufacturing. It introduces the specific contents that are covered in each step of the flowchart such as technical points, matters that needs to be focused on and related regulations of Europe and FDA. It helps the pharmaceutical companies to understand the basic requirements to become an attractive CMO and how to accumulate the advanced experience of international pharmaceutical management during the contract manufacturing. Finally, this article introduces two kinds of globalization models driven by CMO for the enterprise reference. Key Words： CMO, Outsourcing, Pharmace